In a groundbreaking move toward health independence, sub-Saharan Africa has commenced the integration of locally produced HIV medications and diagnostic tools into national health systems—marking the first time African-made treatments have been procured for a national programme like that of Mozambique.
This significant shift comes as the region, which carries nearly 65% of the world’s HIV burden, has historically relied heavily on imported antiretroviral drugs and testing kits.
HIV (Human Immunodeficiency Virus) compromises the immune system, diminishing the body’s ability to ward off infections and cancers. Without appropriate treatment, the virus advances to AIDS (Acquired Immunodeficiency Syndrome), the final and most severe stage.
According to a statement released Friday by the World Health Organization (WHO), Kenya’s Universal Corporation Ltd has become the first pharmaceutical company on the continent to receive WHO prequalification for manufacturing HIV treatment drugs.
The statement, which was obtained by The News Chronicle, revealed that the company earned the certification to produce a fixed-dose combination of tenofovir disoproxil fumarate, lamivudine, and dolutegravir—commonly known as TLD—a preferred first-line regimen for HIV treatment.
In a significant leap forward, the Global Fund—a leading global financing institution in the fight against HIV, tuberculosis, and malaria—is now procuring the locally produced TLD for Mozambique. This marks the first-ever use of African-manufactured TLD in the Global Fund’s supply chain.
“The procurement of the African-manufactured first-line HIV treatment by the Global Fund for Mozambique is a great milestone towards strengthening supply chain systems in Africa,” said Dr Meg Doherty, Director of WHO’s Global HIV Programmes.
“This will contribute to better health outcomes for people living with HIV who need uninterrupted medicine supplies.”
WHO says this breakthrough reflects an overarching strategy to increase regional production of critical health products and reduce reliance on global imports. The organization continues to work with governments, manufacturers, and health partners like the Global Fund and Unitaid to build a more self-reliant healthcare infrastructure in Africa.
“Local production of quality-assured health products is an urgent priority,” said Rogerio Gaspar, WHO Director for Regulation and Prequalification.
“With every African manufacturer that meets WHO prequalification standards, we move closer to a more self-reliant, resilient and equitable health system.”
However, WHO emphasized that merely producing drugs is not enough. Long-term success depends on sustained investments, favorable procurement frameworks, and robust technical support for manufacturers.
Beyond treatment, diagnostics remain a critical area of concern. As donor support shifts, many countries are grappling with the pressure to maintain HIV testing programmes—key to identifying and treating the disease early.
In a related stride, Nigerian diagnostics firm Codix Bio has secured a sublicence to produce rapid HIV test kits. These locally made diagnostic tools are expected to slash costs and ease supply chain disruptions.
“Having locally produced HIV rapid tests will help increase affordability, and more broadly address supply chain vulnerabilities and delays in access to diagnostics,” Doherty noted.
WHO is urging countries to adopt these cost-effective, WHO-prequalified HIV test kits as the primary tool in their national testing protocols, which could significantly reduce spending while preserving quality.
While these achievements signify real progress, WHO insists that further efforts are essential.
“Locally manufactured TLD is a major step towards that goal,” WHO stated, “but more action is needed.”
